Hormone Deficiency
Conditions
Brief summary
Growth hormone and gonadotropin deficiency after brain injury (traumatic brain injury, ischemic stroke, subarachnoidal hemorrhage): the effects of hormone replacement on cognition, quality of life and body composition Randomized, controlled, 3 arm (group 2: double-blind; groups 1 and 3: open), multi-center, pilot study (Phase II)
Detailed description
The aim of the study is to investigate the influence of growth-hormone replacement on cognition, quality of life, body mass index, body composition and reorganization of brain activity of hypopituitary patients in a stable, chronic phase after brain injury compared to control patients and the influence of testosterone replacement in gonadotropin deficient patients compared to placebo treated control patients.
Interventions
DRUGGenotropin
Genotropin administered sc once a day by patient or caregiver.
DRUGTestosterone undecannoate
Testosterone undecannoate administered twice (6 week Interval) im by investigator.
Sponsors
Schoen Clinic Bad Aibling
Max-Planck-Institute of Psychiatry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Group 1: 1. Age 2. F/M 3. Stable phase after TBI, SAH or IS 4. Stable substitution of other hormonal axes 5. GH below 6 ng/ml after stimulation with ITT or GH below cut-off in GHRH/arginine test using BMI-adjusted cut-off limits, GHRH/arginine test should be done only in patients denying or with a contraindication for ITT 6. Written informed consent Group 2: 1. Age 2. M 3. PSA in normal range 4. Stable phase after TBI, SAH or IS 5. Stable substitution of other hormonal axes 6. Below 3.5 ng/ml testosterone 7. Written informed consent Group 3: 1. Age 2. F/M 3. Stable phase after TBI, SAH or IS 4. GH higher 6 ng/ml after stimulation with ITT or GH below cut-off in GHRH/arginine test using BMI-adjusted cut-off limits, GHRH/arginine test should be done only in patients denying or with a contraindication for ITT 5. Written informed consent
Exclusion criteria
Group 1: 1. Pregnancy/lactation period 2. Women of childbearing potential not using an adequate method of birth control 3. Men not willing to use an adequate method of birth control 4. Previous or concomitant medication with GH 5. Hypersensitivity to GH 6. Drug or alcohol abuse 7. Condition which in opinion of investigator makes patient unsuitable for inclusion 8. Participation in another clinical trial with investigational new drug 9. Planned treatment or changes in established treatment with other drug which might significantly influence GH axis or cognitive function 10. Non-ability to perform testing 11. Presence of other conditions listed in contraindications or warnings in local SPC of GH 12. Onset of GH-deficiency before BI Group 2: 1. Men not willing to use an adequate method of birth control 2. Previous or concomitant medication with androgens or anabolic steroids within 12 months 3. Hypersensitivity to active substances or excipients of Nebido® 4. Drug or alcohol abuse 5. Condition which in opinion of investigator makes patient unsuitable for inclusion 6. Participation in another clinical trial with investigational new drug 7. Planned treatment or changes in established treatment with other drug which might influence gonadotrophic axis or cognitive function 8. Severe disturbances in articulation, visual faculty, hearing 9. Presence of other conditions listed in contraindications or warnings in local SPC of Nebido® 10. Onset of hormonal deficiency before BI 11. Suspicion or known history of prostate or breast cancer or other hormone dependent neo plasia as well as history of malignancy within last 5 years 12. Abnormal finding on DRE 13. PSA higher 4 ng/ml 14. History of clinically significant post void residual urine before BI 15. Suspicion or known history of liver tumor 16. Blood coagulation irregularities presenting an increased risk of bleeding after i.m injections 17. Hypercalcemia accompanying malignant tumors 18. Sleep apnea 19. Polycythemia 20. Haematocrit higher than 50 % 21. Concurrent use of DHEA, anabolic steroids, clomipramine, antiandrogens, estrogen, ACTH, corticosteroids, oxyphenbutazone 22. Uncontrolled thyroid disorders like diabetes mellitus, epilepsia, migraine, hypertension, coronary heart disease as well as hepatic, renal or cardiac insufficiency 23. Patients requiring or undergoing fertility treatment 24. Condition which in opinion of investigator makes patient unsuitable for inclusion 25. Non-ability to perform cognitive testing 26. Onset of androgen deficiency before BI. Group 3: 1. Previous or concomitant medication with androgens, GH or anabolic steroids within 12 months 2. Drug or alcohol abuse 3. Condition which in opinion of investigator makes patient unsuitable for inclusion 4. Participation in another clinical trial with investigational new drug 5. Planned treatment or changes in established treatment with other drug which might influence gonadotrophic axis or cognitive function 6. Severe disturbances in articulation, visual faculty, hearing 7. Non-ability to perform cognitive testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 6 months | Quality of Life (QoL) was measured with the following questionnaires prior to treatment and after treatment: * SF-12 short-form health questionnaire (12 items, score: min. 12/max. 47) * QoL-AGHDA Assessment of GHD in Adults (25 items: yes/no answers) * EQ-5 D Euroquol (5 items, scale per items from 1 (no problems) to 3 (severe problems); 1 Likert scale (0 worst-100 best) to measure health status) * BDI Beck Depression Inventory (21 items, score: min. 0/max. 63) * PSQI Pittsburgh Sleep Quality Index: (4 items regarding sleep duration, 11 items regarding sleep quality, 1 item regarding sleeping medication, 2 item regarding daytime dysfunction, 1 item regarding sleeping habit; 5 items for third-party assessment) * QOLIBRI Quality of Life after Brain Injury (37 items, scale per item from 1 (not at all) to 5 (very much) QoL was measured with difference between mean scores of the respective questionnaires, determined before and after treatment. |
Countries
Germany
Outcome results
None listed